Device product
Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N
Z-2607-2026
Product summary
- Event
- Event 99209
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9,272 kits
- Official record key
device-enforcement:Z-2607-2026
Official wording
Reason: Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Code information: DYNJ901328G UDI-DI 10198459601538 Lots 26ABD786 26CBD768 26DBJ434 DYNJ903465K UDI-DI 10198459292743 Lots 25GDB257 26ADA464 26BDA587 26DDA021 DYNJ909090G UDI-DI 10198459406027 Lots 25LBH690 25LBP697 DYNJ906102M UDI-DI 10198459406409 Lots 25JBE315 25KBI700 25KBM827 25LBB028 26ABH106 26CBQ206 DYNJ902664M UDI-DI 10198459349126 Lots 25ILA177 25KLA500 DYNJ902664N UDI-DI 10198459675287 Lot 26BLA783
Distribution pattern: US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Derived failure modes
-
Unknown
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.